Cefadroxil

Product NDC
0093-3196
11-digit product format
000933196
Labeler code
0093
Product ID
0093-3196_86b8951f-3699-4888-9eeb-7bbda995ec35
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefadroxil
Dosage form
CAPSULE
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA065282
Marketing category
ANDA
Marketing start
2007-01-31
Substance
CEFADROXIL
Active strength
500 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cefadroxil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFADROXIL500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii280111G160
Rxcui309049

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
560bed03-0257-a1db-0638-2c46fc35054cProduct name220170824
34f1b9ee-0673-df8c-ddae-36eaf4c48382Product name120140508
3793572a-4958-68b2-f923-8cf695ec1cc1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0093-3196-01Cefadroxil100 in 1 BOTTLECAPSULE10015
0093-3196-53Cefadroxil50 in 1 BOTTLECAPSULE5015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-3196-01EA - Each0093-3196d8400110-fd51-4e48-ab82-462678d80eb212012-07-24
0093-3196-53EA - Each0093-3196f7630525-35e2-4d80-a7c4-7e5ed5a78ef712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFADROXILACTIVE INGREDIENT280111G160CEFADROXIL CAPSULE [TEVA PHARMACEUTICALS USA INC]8
CEFADROXIL ANHYDROUSACTIVE MOIETYQ525PA8JJBCEFADROXIL CAPSULE [TEVA PHARMACEUTICALS USA INC]8
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933CEFADROXIL CAPSULE [TEVA PHARMACEUTICALS USA INC]8
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CEFADROXIL CAPSULE [TEVA PHARMACEUTICALS USA INC]8
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCEFADROXIL CAPSULE [TEVA PHARMACEUTICALS USA INC]8
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEFADROXIL CAPSULE [TEVA PHARMACEUTICALS USA INC]8
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCEFADROXIL CAPSULE [TEVA PHARMACEUTICALS USA INC]8
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACEFADROXIL CAPSULE [TEVA PHARMACEUTICALS USA INC]8
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CEFADROXIL CAPSULE [TEVA PHARMACEUTICALS USA INC]8
GELATININACTIVE INGREDIENT2G86QN327LCEFADROXIL CAPSULE [TEVA PHARMACEUTICALS USA INC]8
INDIGOTINDISULFONATE SODIUMINACTIVE INGREDIENTD3741U8K7LCEFADROXIL CAPSULE [TEVA PHARMACEUTICALS USA INC]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEFADROXIL CAPSULE [TEVA PHARMACEUTICALS USA INC]8
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CEFADROXIL CAPSULE [TEVA PHARMACEUTICALS USA INC]8
SHELLACINACTIVE INGREDIENT46N107B71OCEFADROXIL CAPSULE [TEVA PHARMACEUTICALS USA INC]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEFADROXIL CAPSULE [TEVA PHARMACEUTICALS USA INC]8
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCEFADROXIL CAPSULE [TEVA PHARMACEUTICALS USA INC]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEFADROXIL CAPSULE [TEVA PHARMACEUTICALS USA INC]8
CEFADROXILACTIVE INGREDIENT280111G160CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
CEFADROXIL ANHYDROUSACTIVE MOIETYQ525PA8JJBCEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
GELATININACTIVE INGREDIENT2G86QN327LCEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
SHELLACINACTIVE INGREDIENT46N107B71OCEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-3196CEFADROXIL CAPSULE [TEVA PHARMACEUTICALS USA, INC.]15Current NDC, Legacy NDC, 2 package rows20250306_bda86975-8c2f-4c4e-9a4c-a1a959f9336a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309049cefadroxil 500 MG Oral CapsulePSNbda86975-8c2f-4c4e-9a4c-a1a959f9336a15
309049cefadroxil 500 MG Oral CapsuleSCDbda86975-8c2f-4c4e-9a4c-a1a959f9336a15
309049cefadroxil (as cefadroxil monohydrate) 500 MG Oral CapsuleSYbda86975-8c2f-4c4e-9a4c-a1a959f9336a15
309049cefadroxil 500 MG Oral CapsulePSN45ac01b1-b5b7-6fc1-e063-6394a90a271a1
309049cefadroxil 500 MG Oral CapsulePSNf4ed87ce-e0e1-0054-e053-2a95a90a979c1
309049cefadroxil 500 MG Oral CapsuleSCD45ac01b1-b5b7-6fc1-e063-6394a90a271a1
309049cefadroxil 500 MG Oral CapsuleSCDf4ed87ce-e0e1-0054-e053-2a95a90a979c1
309049cefadroxil (as cefadroxil monohydrate) 500 MG Oral CapsuleSY45ac01b1-b5b7-6fc1-e063-6394a90a271a1
309049cefadroxil (as cefadroxil monohydrate) 500 MG Oral CapsuleSYf4ed87ce-e0e1-0054-e053-2a95a90a979c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-3196-0100093319601100 CAPSULE in 1 BOTTLE (0093-3196-01) 100 capsule2007-01-310000-00-00NoNoCurrent
0093-3196-530009331965350 CAPSULE in 1 BOTTLE (0093-3196-53) 50 capsule2007-01-310000-00-00NoNoCurrent